Cache of job #13962350

Job Title

QA CSV Mes Specialist

Employer

Pe Global

Location

Dublin North

Description

QA CSV Specialist. PE Global requires a QA CSV Specialist for one of our client sites in North Dublin, this position will be for 12 months initially. The Quality Assurance (CSV) Specialist ensures that computerized systems for the facility comply with corporate policies, GMP and regulatory requirements over the entire system lifecycle. As a quality and compliance representative, the QA Specialist will be a key member of the MES Project team. This key role will provide the appropriate oversight for the implementation, validation and system modification of the MES System to ensure that the implemented batch records meet corporate policies, GMP and regulatory requirements. Principal Responsibilities. Provide quality oversight and compliance support to implement and validate electronic systems in accordance with site computer system validation (CSV) procedures and requirements. Review and approval of CSV and Qualification documents such as validation plans, protocols, test scripts, validation reports etc. Serve as the QA CSV Subject Matter Expert for implementation and verification of Manufacturing Execution System (MES. Provide Quality oversight for project deviations ensuring all are appropriately investigated and documented with appropriate corrective and preventative actions in place. Support and review changes throughout the verification/validation phase and post release of the system through the change control system. Participate and provide quality oversight in any required system risk assessments. Review and approval of systems administration maintenance procedures to ensure computer systems are in a state of control. Support internal and external audits and system vendor qualification activities. Provide Quality Management with project updates, and communicate risk based escalation of issues as required. Interface with relevant departments to ensure compliance with corporate policies, GMP and regulatory requirements. Any other duties as required by management. Qualifications. Min 8 years QA experience in a pharmaceutical manufacture/biopharmaceutical environment. Must have strong technical knowledge of Computer System Validation. Must have strong understanding of 21 CFR Part 11, Annex 11and Data Integrity Guidance’s and ability to assess compliance risks. Must have an ability to work independently, as well as a member of a team in a dynamic, fast-paced environment. Excellent communication & presentation skills are essential. Excellent time management organizational skills along with a proven ability to multi-task. Education. B.Sc. in science/pharmacy with a minimum of 8 years’ experience in cGMP Quality environment to include biopharmaceutical experience. Please send in your Cv for the attention of Robert Carroll or contact 021 4520311 or robert.carroll@peglobal.net for more information. Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert. This job originally appeared on RecruitIreland.com.

Date Added

1962 days ago

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